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Breaking Lawsuit NewsWed, 07 Sep 2016 19:15:18 +0000en-UShourly1https://wordpress.org/?v=4.7.5Flawed Testing Process May Conceal Lead Risk in NYC School Waterhttp://www.breakinglawsuitnews.com/flawed-testing-process-may-conceal-lead-risk-in-nyc-school-water/
Wed, 07 Sep 2016 19:15:18 +0000http://www.breakinglawsuitnews.com/?p=7607In July, when New York officials announced the results of testing for lead in the water at more than 1,500 New York City school buildings, they said less than 1 percent of samples showed lead concentrations that exceeded Environmental Protection Agency (EPA) guidelines. The officials assured parents, the water was safe to drink. But a […]

]]>In July, when New York officials announced the results of testing for lead in the water at more than 1,500 New York City school buildings, they said less than 1 percent of samples showed lead concentrations that exceeded Environmental Protection Agency (EPA) guidelines. The officials assured parents, the water was safe to drink.

But a review of how the testing was conducted suggests that the amount of lead in the water that students consume could be greater than the results indicate, the New York Times reports.

The night before samples were taken, water outlets in the schools were turned on fully for two hours. This “pre-stagnation flushing” cleans most soluble lead and lead particles from pipes and thus reduces lead levels temporarily, according to the Times. In February, however, the Environmental Protection Agency (EPA) recommended against pre-stagnation flushing saying that flushing “may potentially lower the lead levels as compared to when it is not practiced.” The EPA does not regulate the testing of water in schools, but its guidelines for school water testing recommend mimicking normal water consumption patterns when taking samples, according to the Times.

Prof. Mark Edwards, a professor of civil engineering at Virginia Tech says, “The results should be thrown into the garbage, and the city should start over.” Prof. Edwards helped uncover the dangerously high lead levels in the water in Flint, Michigan. The Flint water crisis touched off scrutiny into lead contamination of drinking water nationwide.

Dr. Yanna Lambrinidou, who has worked with Dr. Edwards on water testing in Washington, D.C., and elsewhere, said, “Flushing is inappropriate any time you want to assess lead concentrations coming out of individual taps.” Lambrinidou said water in schools is often stagnant for long periods because water is not used after school hours, or on weekends, holidays, and other breaks. Sample should be taken under conditions similar to conditions when children drink the water, Lambrinidou said.

Dan Kass, a deputy commissioner in the city’s Department of Health and Mental Hygiene, said flushing is intended to create a consistent baseline for the tests, regardless of whether the samples were taken on a Monday morning after a building had been closed for the weekend or collected on another day of the week, according to the Times.

After contractors finished flushing in school buildings, they left for about eight hours and returned around 5 a.m. to take samples. At each tap or outlet, they took a sample of the first water out of the tap, known as the first draw. Then the water was run for 30 seconds before the second draw was taken. When a second-draw sample shows an elevated lead concentration, this indicates a problem with a more sustained source of lead in the plumbing, the Times explains.

Michigan officials have been criticized for advising flushing before residents took water samples in their homes. Experts say flushing hid the severity of the lead problem in many homes. Two state environmental officials have been charged with violating the Michigan Safe Drinking Water Act with the flushing instructions.

Five hundred ten of the New York City’s 1,520 occupied school buildings had at least one outlet where the first-draw water sample had a lead concentration over 15 parts per billion, the EPA’s “action level” for lead in municipal water systems. And 153 buildings had at least one outlet where the second-draw sample exceeded the threshold. Eight buildings had at least one outlet with a lead concentration over 500 parts per billion.

Lead exposure is particularly dangerous for young children. The Centers for Disease Control and Prevention (CDC) says here is no known identified safe blood lead level. “Exposure to lead can seriously harm a child’s health.” High levels of lead in the blood can affect mental development and damage organs. Even low levels of lead can affect intellectual development, the ability to pay attention, and academic performance.

]]>Proposed $250 Million Settlement Announced in GranuFlo/NaturaLyte Litigationhttp://www.breakinglawsuitnews.com/proposed-250-million-settlement-announced-in-granuflonaturalyte-litigation/
Fri, 19 Feb 2016 17:54:41 +0000http://www.breakinglawsuitnews.com/?p=7604On February 16, 2016, a day after a bellwether trial was scheduled to begin in Massachusetts federal court, Fresenius Medical Care announced a proposed $250 million settlement in multidistrict litigation over side effects from its dialysis drugs GranuFlo and NaturaLyte. The plaintiffs accused Fresenius of concealing knowledge that after taking GranuFlo and NaturaLyte, the patient’s body can […]

]]>On February 16, 2016, a day after a bellwether trial was scheduled to begin in Massachusetts federal court, Fresenius Medical Care announced a proposed $250 million settlement in multidistrict litigation over side effects from its dialysis drugs GranuFlo and NaturaLyte.

The plaintiffs accused Fresenius of concealing knowledge that after taking GranuFlo and NaturaLyte, the patient’s body can produce chemical compounds that could eliminate too much acid in the blood, Law360 reports.

The plaintiffs claim Fresenius concealed its knowledge that chemical compounds produced in the body after taking GranuFlo and NaturaLyte could cause too much acid to be eliminated, creating an electrical imbalance that could cause the heart to stop beating. Fresenius issued warnings about this in 2011 and 2012, though the warnings were not based on studies it had conducted, but on research conducted by doctors and the U.S. Food and Drug Administration (FDA). The company said it continues to doubt the science behind those findings, according to Law360.

The agreement calls for $250 million to be awarded to the plaintiffs if 97 percent of those eligible agree to the terms by July 2016. The funding would be provided the following month, Law360 reports. About $220 million would come from insurance companies; Fresenius would pay about $60 million for the remaining settlement amount and associated costs.

Fresenius says it stands behind the safety of GranuFlo and NaturaLyte. Fresenius said GranuFlo and NaturaLyte remain on the market and continue to be “the market leader for dialysis acid concentrates in the United States.” The company expects revenues of about $16.7 billion for 2015. Fresenius says there has been no change in the composition of either product, Law360 reports. GranuFlo/NaturaLyte “remains safe and effective when used and prescribed as directed.” In the lawsuit, the plaintiffs say that while dialysis patients require the blood-filtering treatment to reduce acid levels in their blood, eliminating too much acid can also be dangerous.

The U.S. Judicial Panel on Multidistrict Litigation consolidated GranuFlo and NaturaLyte claims in the Massachusetts court in 2013. The MDL eventually absorbed suits filed by patients, relatives, and attorneys general from Louisiana and Mississippi, but U.S. District Judge Douglas P. Woodlock returned those cases to those states last year.

]]>Flint Water Crisis Leads to Class Action Suits Seeking Compensationhttp://www.breakinglawsuitnews.com/flint-water-crisis-leads-to-class-action-suits-seeking-compensation/
Mon, 15 Feb 2016 17:05:30 +0000http://www.breakinglawsuitnews.com/?p=7601Flint, Michigan residents, suffering health problems and financial burdens brought on by the lead in their drinking water, have begun seeking legal remedies. The city’s 100,000 were exposed to high levels of lead in their tap water after the city changed water sources in 2014 in an effort to save money. The water is particularly […]

]]>Flint, Michigan residents, suffering health problems and financial burdens brought on by the lead in their drinking water, have begun seeking legal remedies. The city’s 100,000 were exposed to high levels of lead in their tap water after the city changed water sources in 2014 in an effort to save money. The water is particularly dangerous to young children, whose brains and bodies are still developing. Lead exposure can cause irreversible problems including lower IQ, learning difficulties, and behavioral problems.

Class-action lawsuits are a legal route to compensation, according to the Washington Post. Suits have already been filed, focusing on the actions of the Department of Health and Human Services, the state of Michigan and state agencies.

In a public health crisis like this one, corporations and governments will attempt to evade responsibility until citizens are able to muster the evidence to prove harm. A legal team can help plaintiffs assemble the documentation they need and the medical and scientific experts to support their claims. In a civil suit, the plaintiff must prove that a “preponderance,” or majority, of the evidence demonstrates liability, and then the defendants are held responsible and are required to provide financial compensation.

The Flint situation is more difficult than a suit against a private party because the allegations are directed at government agencies. Under Michigan law, residents seeking compensation from a public agency are required to prove not merely negligence, but gross negligence, that is, “conduct so reckless as to demonstrate a substantial lack of concern for whether an injury results.” Wayne State University law professor John Mogk says that when “it’s a governmental function, the government itself has almost total immunity,” though “employees can be liable if they are grossly negligent,” the Detroit Free Press reports. The Washington Post reports that state officials knew about the crisis and protected themselves by providing bottled water to state workers well before they publicly acknowledgment to the citizens of Flint that the water was tainted.

Class actions of this type are hard to win because it is difficult to demonstrate a direct causal relationship between the defendant’s reckless disregard and the plaintiff’s injury. To win, plaintiffs must bring in recognized experts in the issues, with “a solid understanding of chemistry and toxicology,” according to the Post. If government agencies are found liable in a class-action suit, individual damage claims may have to be litigated on their own merits, unless a settlement is offered. Different members of the class will have different categories and severity of injuries and will therefore be entitled to different levels of compensation.

Flint residents who have been drinking, cooking with or bathing in Flint’s water should see a doctor for blood lead level tests and to document health problems arising from exposure to the tainted water. The Post explains that many Flint residents will need long-term medical monitoring for latent diseases that can take years to manifest. Children may need educational support because of deficits caused by lead exposure.

Residents should save their water bills, medical and pharmaceutical bills, receipts for purchases of bottled water, and any other documentation of financial burdens. Please contact 1-800-LEAD-LAW for further information.

]]>More Expert Witnesses Testify in DePuy Pinnacle Trialhttp://www.breakinglawsuitnews.com/more-expert-witnesses-testify-in-depuy-pinnacle-trial/
Wed, 03 Feb 2016 01:13:42 +0000http://www.breakinglawsuitnews.com/?p=7598In the Northern District of Texas, five lawsuits over the DePuy Pinnacle metal-on-metal hip implant have been consolidated into one bellwether trial before federal Judge Ed Kinkeade. Over the past four weeks, jurors have been hearing arguments over whether the metal hip implant is to blame for injuries such as metal poisoning. Plaintiffs in the […]

]]>In the Northern District of Texas, five lawsuits over the DePuy Pinnacle metal-on-metal hip implant have been consolidated into one bellwether trial before federal Judge Ed Kinkeade. Over the past four weeks, jurors have been hearing arguments over whether the metal hip implant is to blame for injuries such as metal poisoning. Plaintiffs in the litigation, as with other cases over metal-on-metal hip implants, allege the implant fails at high rates and sheds metal debris.

In 2010, DePuy issued a global recall of its ASR metal-on-metal hip implants because the devices were failing at higher rates than expected. In other words, patients who received the ASR experienced complications within a relatively short period of time resulting in a second surgery, known as a revision surgery, to remove the implant. The ASR recall brought concerns over metal-on-metal hip implants to light, and thousands of lawsuits have been filed. DePuy Orthopaedics created a settlement program in 2013 to handle ASR injury claims.

Plaintiffs allege the Pinnacle hip implant is defective in design and caused complications such as pain, implant loosening, tissue death and elevated metal ion levels. A number of studies have linked all-metal hip devices to higher rates of failure. DePuy is accused of failing to warn about these problems.

World renowned orthopedic histopathologist Dr. Nicholas Athanasou, M.D., Ph.D recently testified in the Pinnacle trial. Dr. Athanasou studied cellular mechanisms of bone resorption and is a professor of musculoskeletal pathology at Oxford, England. DePuy objected to his use of a microscope in the courtroom, but the court overruled this motion. His testimony will proceed.

Other recent plaintiff expert witnesses include top orthopedic surgeon Dr. Bernard Morrey and his son Dr. Matt Morrey. Dr. Bernard Morrey, who has vast credentials including over 30 years with the Mayo Clinic, told jurors he has never used metal-on-metal hip implants. Both doctors are non-retained experts for the plaintiffs. The court asked Dr. Matt Morrey to provide a report and he may be required to return for further examination.

]]>Boston Scientific Sued for Racketeering and Use of Counterfeit Plastichttp://www.breakinglawsuitnews.com/boston-scientific-sued-for-racketeering-and-use-of-counterfeit-plastic/
Wed, 20 Jan 2016 13:14:05 +0000http://www.breakinglawsuitnews.com/?p=7593Device maker Boston Scientific has been sued under the Racketeering and Corrupt Organizations Act (RICO) for allegedly orchestrating a conspiracy to sell transvaginal mesh made from counterfeit plastic smuggled from China. Transvaginal mesh devices are implanted in about 55,000 women each year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The polymer […]

]]>Device maker Boston Scientific has been sued under the Racketeering and Corrupt Organizations Act (RICO) for allegedly orchestrating a conspiracy to sell transvaginal mesh made from counterfeit plastic smuggled from China.

Transvaginal mesh devices are implanted in about 55,000 women each year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The polymer used to make all of Boston Scientific’s mesh, the polypropylene Marlex HGX-030-1, had been specified in regulatory documents filed for Boston Scientific’s mesh products. No other polymers could be used in its current mesh products, Qmed reports.

In 2011, the company began to encounter difficulties obtaining the material from its supplier, Chevron and Phillips/Sumika in LaPorte, Texas. When Boston Scientific was unsuccessful in its attempt to convince Phillips to produce the material, the company allegedly began smuggling the material out of China. According to Qmed, Boston Scientific worked with a “known counterfeiter,” EMAI Plastic Raw Materials, and ultimately smuggled some 34,000 pounds of counterfeit Marlex material, without verifying the contents. Marlex is a trademarked brand name.

Qmed reports that counterfeit Marlex resin pellets were reportedly sent to Belgium to produce counterfeit Marlex fibers, and then Ireland to fashion the fibers into shaped mesh, and finally to Indiana for final knitting and manufacture. The legal complaint says Boston Scientific “took extraordinary measures to avoid being caught by U.S. and Chinese authorities, at times acting like a drug dealer to hide multiple overseas shipments.”

An email from an attorney involved in the case alleges that the counterfeit mesh had levels of selenium 10 times the amount allowed in Europe for general plastics, such as those used in plastic furniture. Selenium is not present in Marlex resin. The attorney claims that the element will react with hydrogen peroxide to cause inflammation, degrading both the plastic itself and the surrounding tissue.

The legal complaint says the smuggling operation required deceiving Chinese customs, U.S. customs, the Food and Drug Administration, and, ultimately, the patients who were implanted with the adulterated products, according to Qmed. The scheme is documented in thousands of Boston Scientific’s own documents, according to the complaint.

The companies claimed they had obtained legitimate Marlex resins in storage from Chevron Phillips Chemical, but lacked the documentation to demonstrate the origin of the material.

Thousands of lawsuits have been filed against Boston Scientific and other makers of transvaginal mesh devices because of injuries and side effects women have suffered. According to the FDA, the most common side effects associated with transvaginal mesh devices include:

mesh erosion through the vagina (also called exposure, extrusion, or protrusion)

pain

infection

bleeding

pain during sexual intercourse

organ perforation

urinary problems

Some women have needed additional surgery to attempt to remove the mesh and repair damage to organs.

The FDA has proposed a reclassification of mesh devices from Class II to Class III. This would mean that mesh devices have to undergo a more stringent clearance process, including clinical trials, to determine if the devices are safe and effective.

]]>Congress Extends Zadroga 9/11 Health and Compensation Act in Year-End Spending Billhttp://www.breakinglawsuitnews.com/congress-extends-zadroga-911-health-and-compensation-act-in-year-end-spending-bill/
Mon, 21 Dec 2015 14:32:56 +0000http://www.breakinglawsuitnews.com/?p=7588Included in the omnibus spending bill passed by Congress on December 18, was an extension of health benefits to 9/11 responders and survivors who suffer illnesses and injuries from the September 11, 2001 terrorist attacks and their aftermath. The bill extended the health care benefits for 75 years, until 2090, the New York Daily News […]

]]>Included in the omnibus spending bill passed by Congress on December 18, was an extension of health benefits to 9/11 responders and survivors who suffer illnesses and injuries from the September 11, 2001 terrorist attacks and their aftermath.

The bill extended the health care benefits for 75 years, until 2090, the New York Daily News reports. Joseph Zadroga, father of detective James Zadroga for whom the act is named, said, “It’s a very good day.” James Zadroga died in January 2006 from illness caused by toxic exposures at ground zero.

The World Trade Center Health Program had already expired because Congress failed to meet the September 30 deadline to extend it. The program continued to run on the remaining funds but would have lapsed entirely next year. The Victim Compensation Fund was set to expire in October 2016. The new legislation extends the health care program through 2090 and the Victims Compensation Fund for another five years to provide benefits to first responders too sick to work and to their families, according to the Daily News.

Rep. Caroline Maloney, one of the leaders in the bipartisan effort to reauthorize the Zadroga Act, was pleased that “the heroes and survivors of 9/11 will know that their health care is permanent and their compensation is full.” Mayor Bill de Blasio described the reauthorization as a “long overdue victory for the 72,000 brave men and women around the country who rely on these programs.”

Citizens for Extension of the Zadroga Act says that more than 200 New York City police officers and firefighters have died from 9/11-related illnesses and about 33,000 responders and survivors suffer a variety ailments, including chronic diseases like asthma, pulmonary disease and gastric reflux. Medical researchers have identified more than 50 types of cancer linked to toxins released when the towers fell. While some responders and survivors became ill soon after 9/11, many 9/11-related illnesses, took years to develop. Tens of thousands of people were exposed to toxic dust and other toxins and health experts expect illnesses to continue to emerge.

Reauthorization of the Zadroga Act took years, the Daily News reports. First responders, recovery workers, survivors, and their supporters made dozens of trips to the Capitol to urge Congress to extend the Victim Compensation Fund and the World Trade Center Health Program.

New York Senator Kirsten Gillibrand, a key supporter of the original act and the extension, said, “This is a very important moment for all of us.” “This is my proudest day in Washington,” Gillibrand said. Rep. Jerry Nadler echoed Gillibrand, “I can finally say I’m proud of my country . . . Our heroes deserve never to worry that their health care will disappear, or that their families will struggle because of 9/11.” Sen. Charles Schumer said those who rushed to the towers “will know that if they get sick because of their bravery, the federal government will be there for them.”

The Zadroga Act reauthorization was part of an omnibus spending bill that keeps the government funded. The measure passed in the House by a vote of 316-113 and in the Senate by a 65-33 vote.

]]>Year-End Spending Bill Before Congress Contains Renewal of Zadroga 9/11 Health and Compensation Acthttp://www.breakinglawsuitnews.com/year-end-spending-bill-before-congress-contains-renewal-of-zadroga-911-health-and-compensation-act/
Fri, 18 Dec 2015 14:11:34 +0000http://www.breakinglawsuitnews.com/?p=7585An $8.1 billion measure to extend the James Zadroga 9/11 Health and Compensation Act is part of the omnibus spending bill expected to be passed by Congress this week. The legislation provides benefits to first responders who became ill after the September 11 attacks. The Zadroga Act renewal is part of the $1.1 trillion year-end […]

]]>An $8.1 billion measure to extend the James Zadroga 9/11 Health and Compensation Act is part of the omnibus spending bill expected to be passed by Congress this week. The legislation provides benefits to first responders who became ill after the September 11 attacks.

The Zadroga Act renewal is part of the $1.1 trillion year-end tax and spending bill, according to ABC7 (New York). If the bill passes, the Victim Compensation Fund will be fully funded through 2021, and the World Trade Center Health program will be renewed until 2090.

The WTC Health Program funding expired in October 2015 and the VCF was set to expire in October 2016. New York’s junior senator, Kirsten Gillibrand, worked to pass the original legislation and has been a key member of the bipartisan group of 37 senators and 151 House members working for permanent extension of the Zadroga Act. Sen. Gillibrand said, “Our 9/11 first responders never should have been forced to travel to Washington and walk the halls of Congress—legislation this important shouldn’t have needed so much convincing—but after dozens of trips, they finally got the job done.”

The James Zadroga 9/11 Health and Compensation Act, named for an NYPD officer who died of a respiratory illness caused by his participation in the 9/11 rescue and recovery effort, was signed into law in 2011. The act established the Victim’s Compensation Fund to provide compensation to responders and survivors who suffered injuries and economic losses because of the 9/11 terrorist attacks. The World Trade Center (WTC) Health Program provides medical treatment and monitoring. The WTC Health Program monitors more than 70,000 people and treats about 33,000. Health experts expect that 9/11 illnesses will continue to emerge for years to come.

The senior senator from New York, Sen. Charles Schumer, called the Zadroga Act extension “the Christmas the 9/11 responders deserved: some peace of mind for each and every hero. Their selfless actions in response to that tragic day deserve a lifetime’s worth of care and respect.”

The Zadroga Act programs are crucial to many responders who suffer from serious medical conditions as a result of toxic exposures on 9/11 and during recovery operations. While some responders and survivors became ill soon after 9/11, many 9/11-related illnesses, including lung problems and a number of cancers, took years to develop. Thousands of people involved in the rescue and recovery effort were exposed to a wide array of toxic chemicals, carcinogens, asbestos, and pulverized cement released into the air when the Twin Towers fell. Their illnesses include asthma, obstructive pulmonary disease, gastroesophageal reflux disease, and more than 50 types of cancer.

Citizens for Extension of the Zadroga Act reports that more than 85 NYPD officers and 130 firefighters have died from injuries and illnesses since the 2001 attacks. More than 33,000 9/11 responders, recovery workers, and survivors have been diagnosed with an injury or illness linked to the attacks, or their aftermath. Many people suffer from more than one 9/11-related illness and many of them are disabled and no longer able to work. Zadroga Act compensation and coverage of medical costs are crucial to them and their families.

]]>A team of Harvard scientists has just published a study in the peer-reviewed journal Environmental Health Perspectives showing that candy-flavored e-cigarette liquid contains chemicals that cause the serious lung disease Popcorn Lung.

The study results reveal that 75 percent of the 51 flavored liquids tested contain diacetyl and other harmful compounds, the Harvard Gazette reports.

Fruit flavor diacetyl, alcohol flavor diacetyl, and candy flavor diacetyl are some of the culprit ingredients associated with the serious and irreversible lung disease, bronchiolitis obliterans, commonly known as Popcorn Workers Lung or Popcorn Lung. Popcorn Lung is an obstructive lung disease in which the bronchioles of the lungs are blocked by the growth of fibrous tissue. The name traces to the illness developed by employees at a popcorn factory in Missouri that made artificial butter flavoring for microwave popcorn. The workers inhaled diacetyl from the flavoring on a daily basis and developed respiratory symptoms and other symptoms, according to the National Institute for Occupational Safety and Health (NIOSH).

The symptoms of Popcorn Lung (bronchiolitis obliterans) usually occur gradually and become progressively worse. Symptoms include:

Coughing (usually without phlegm)

Shortness of breath on exertion

Fever

Night sweats

Weight loss

Difficulty blowing air out fast and no improvement with asthma medication

Diacetyl, the chemical associated with the development of bronchiolitis obliterans, is a component in a number of the flavorings used in e-cigarette liquids. These chemicals include alpha-diketones 2,3-butanedione, 2,3-butanedione, and 2,3-pentanedione, and acetyl propionyl and they may be responsible for flavorings related lung disease.

People who “vape”—the practice of smoking with e-cigarette devices—with flavored e-cigarette liquids regularly inhale diacetyl. E-cigarettes are increasingly popular among teenagers, and although minors cannot buy traditional cigarettes, they can buy e-cigarettes in many states. At the urging of doctors and public health officials, the Food and Drug Administration (FDA) has proposed new regulations that would include a prohibition on the sale of e-cigarettes to minors.

The Harvard researchers tested 51 types of flavored e-cigarettes and liquids for the presence of diacetyl, acetoin, and 2,3-pentanedione, flavoring compounds that the Flavor and Extract Manufacturers Association lists as “high priority,” for respiratory hazard in the workplace, the Harvard Gazette reports. The flavors tested included fruit and candy varieties that appeal to young e-cigarette users.

To test for the dangerous chemicals, the researchers inserted each e-cigarette into a sealed chamber attached to a device that drew air through the e-cigarette for eight seconds at a time with a resting period of 15 or 30 second between each draw. They analyzed the air stream.

Dr. David Christiani, of the Harvard T.H. Chan School of Public Health was one of members of the research team and was co-author of a paper based on the study. Christiani said the e-liquids contained not only the addictive substance nicotine but also cancer-causing chemicals, such as formaldehyde, and flavoring chemicals that can cause lung damage, according to the Harvard Gazette.

]]>$11 Million Damage Award in First Bellwether Trial for Wright Conserve Hip Devicehttp://www.breakinglawsuitnews.com/11-million-damage-award-in-first-bellwether-trial-for-wright-conserve-hip-device/
Wed, 02 Dec 2015 05:34:04 +0000http://www.breakinglawsuitnews.com/?p=7579The first federal bellwether trial involving the Wright Conserve metal hip implant ended with a damage award $11 million for the plaintiff. Court documents reveal that a Georgia jury returned the $11 million verdict against Wright Medical Technology. Ten million dollars was punitive damages and the remaining $1 million was compensatory damages. More than 500 […]

]]>The first federal bellwether trial involving the Wright Conserve metal hip implant ended with a damage award $11 million for the plaintiff.

Court documents reveal that a Georgia jury returned the $11 million verdict against Wright Medical Technology. Ten million dollars was punitive damages and the remaining $1 million was compensatory damages. More than 500 similar lawsuits are pending in a federal multidistrict litigation (MDL).

The two-week trial concluded on November 24, 2015. The lawsuit was filed on behalf of a woman who was implanted with the Conserve hip, a metal-on-metal hip replacement device, in 2006. She was later diagnosed with a loosened and displaced acetabular cup and she underwent additional surgery in 2012. The lawsuit alleged that during the second surgery the surgeon discovered signs of metallosis (metal poisoning), which was causing soft tissue damage. The lawsuit alleged that the Conserve hip was defectively designed and that the company failed to warn surgeons and patients about the risks associated with the device.

In the pending lawsuits in the federal MDL, plaintiffs allege that the metal-on-metal design of the Wright hip implant devices caused complications including pain, swelling, tissue damage, device loosening, metallosis, hip dislocation, and other injuries. A number of recipients of the Conserve hips underwent revision surgery to remove the defective implant and replace it with a different device.

Thousands of lawsuits have been filed against makers metal hip device makers, including Johnson & Johnson’s DePuy Orthopaedics and Stryker Orthopaedics. Metal-on-metal hip implants have come under increasing scrutiny because of mounting injury reports and growing evidence in the medical literature of the risk of adverse reactions. Serious complications can arise when the metal surfaces of the hip implant rub together during normal activities, such as walking. Metal-on-metal hip devices have shown higher than expected early failure rates and many have been removed from the market.

The Georgia case was a bellwether trial—a case representative of similar claims brought by a number of other plaintiffs. To manage a large caseload of similar cases, the parties choose representative cases to be the first to go to trial. The results of the bellwether cases can indicate trends in the litigation. Bellwether cases often provide the basis for reaching a settlement in other cases. The verdict in the Georgia case could have “a powerful impact on the remaining cases,” according to an attorney involved in metal-on-metal hip device litigation.

Another Wright hip device, the Wright Profemur Hip Replacement System, has also been the subject of litigation. The first Profemur trial concluded in June 2015 with a $4.5 million award; the jury found the device to be defectively designed. The award consisted of $4 million for past and future pain and suffering for the man who had received the Profemur hip, and $500,000 to his wife.

]]>Mentor Corp. Settles Transvaginal Mesh Case Just Ahead of Bellwether Trialhttp://www.breakinglawsuitnews.com/mentor-corp-settles-transvaginal-mesh-case-just-ahead-of-bellwether-trial/
Mon, 16 Nov 2015 19:51:25 +0000http://www.breakinglawsuitnews.com/?p=7576Mentor Corp, a unit of Johnson & Johnson, has settled a transvaginal mesh case less than three weeks before the bellwether trial was scheduled to begin. Mentor filed settlement documents in Georgia federal court last week, settling a case involving the company’s ObTape vaginal sling. According to the documents, the company was accused of making defective […]

]]>Mentor Corp, a unit of Johnson & Johnson, has settled a transvaginal mesh case less than three weeks before the bellwether trial was scheduled to begin.

Mentor filed settlement documents in Georgia federal court last week, settling a case involving the company’s ObTape vaginal sling. According to the documents, the company was accused of making defective pelvic mesh implants that cause painful infections and other complication, Law360 reports. The trial would have started on November 30.

The case was among six cases designated as bellwethers by U.S. District Judge Clay D. Land, Law360 reports. A bellwether trial is one in which the plaintiff’s claims are similar to claims brought by a number of other plaintiffs. To manage a large caseload of similar cases, the parties choose a group of plaintiffs to represent all the plaintiffs. The representative cases go to trial and the results of the bellwether cases can indicate trends in the litigation. Bellwether cases often provide the basis for reaching a settlement in other cases.

Pelvic mesh (transvaginal mesh) is surgically implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. POP occurs when the pelvic structures that support the bladder, uterus and bowel, become weak, stretched, or torn and the organs can slip from their normal position and bulge (prolapse) into the vagina, the Food and Drug Administration (FDA) explains. POP can cause pain and disruption of sexual, bladder, and bowel functions. Loss of bladder control (SUI) is embarrassing and has tremendous negative impact on the woman’s life. But many women experience serious injuries and complications from the device that supposed to correct POP and SUI. Women experience erosion of the mesh through the vaginal lining, urinary problems, infection, pain, and recurrence of prolapse or incontinence. The bowel, bladder, and blood vessels have been perforated during insertion of the mesh device, the FDA reports.

In the ObTape cases, Mentor faces claims of negligence, fraudulent concealment, breaches of express and implied warranties and failure to warn, Law360 reports. The woman plaintiff in the settled case was implanted with the ObTape device in 2004. By 2011, she had suffered infections, abscesses and scarring that required multiple surgeries, according to Law360.

In 2014, the FDA issued two proposed orders to address the health risks associated with transvaginal mesh. If the orders become final, transvaginal mesh devices would be reclassified from the FDA’s moderate-risk device (Class 2) to the high-risk Class 3. Manufacturers would have to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

Mentor settled 111 ObTape cases the day before the U.S. Judicial Panel on Multidistrict Litigation consolidated the ObTape suits into a multidistrict litigation (MDL), Law360 reports. The agreed to establish a trust to manage and distribute funds agreed upon in 2014. Transvaginal mesh manufacturers C.R. Bard, Boston Scientific, Ethicon (Johnson & Johnson division), Coloplast, and Cook Medical are involved in multidistrict litigations in New Jersey and West Virginia.